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RecruitingPhase NA

The Effect of Different Diets on Arterial Stiffness in Obese Patients on Semaglutide

The Effect of Mediterranean or High Protein/Low Carbohydrate Diet on Arterial Stiffness in Non-diabetic, Obese Patients on Semaglutide: A Randomized Controlled Trial

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

60

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI ≥30

Primary endpoint

CfPWV measurement and pulse wave analysis (PWA)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04990024
Org study IDBIO-2020-0136

Timeline

Milestones

Study start2021-07-01actual
Study first posted2021-08-04actual
Last update posted2024-08-06actual
Primary completion2025-09-15estimated
Study completion2025-09-15estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age49 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Men and premenopausal women, 18-49 years, with obesity defined as BMI ≥ 30 kg/m2
Upon the initiation of Semaglutide (within the first 1-4 weeks) for medical weight management, for clinical purposes, as advised by the primary physician
Able to commit for a 6-month trial visits

Exclusion criteria

Pregnant women
Patients who are taking or have taken other weight reducing drug therapies in the previous 6 months
Patients who have undergone metabolic weight loss surgery
Patients known to have diabetes (HbA1c ≥6.5% at screening)
Patients with uncontrolled hypertension
Patients with uncontrolled cardiac disease, pulmonary, renal or liver diseases, active cancer or psychiatric diseases
Patients with excessive alcohol intake, defined as ≥ 2 glasses per day
Patients known to have uncontrolled/ untreated thyroid disorders.
Patients with cushing disease or polycystic ovaries, and those with neuro-endocrine or drug induced obesity (such as anti-psychotic, steroids, hormonal therapy): Such patients are resistant to weight loss, and they need treatment of their primary disease and/or cessation of the culprit medication to lose weight
Patients with untreated gout
Patients who have undergone bariatric surgery

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
6
Weight & body composition
5
Cardiometabolic biomarkers
3
Patient-reported / QoL
1

Weight & body composition

5 endpoints
Secondary/protocol endpoint

Body composition - visceral adipose tissue using dual x-ray absorptiometry (DXA)

Time frame:6 months after enrollment

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Body composition - percent fat-free body mass using dual x-ray absorptiometry (DXA)

Time frame:6 months after enrollment

descriptive

Secondary/protocol endpoint

Body composition - percent body fat using dual x-ray absorptiometry (DXA)

Time frame:6 months after enrollment

Total fat mass

descriptive, improvement

Other/protocol endpoint

Anthropometric measurements - weight in kilograms, height in centimetres, aggregated into BMI (kilogram per meter squared).

Time frame:6 months after enrollment

descriptive

Other/protocol endpoint

Anthropometric measurements - waist and hip circumference in centimetres, aggregated into waist to hip ratio ratio

Time frame:6 months after enrollment

ratio, improvement

Cardiometabolic biomarkers

3 endpoints
Other/protocol endpoint

Vital signs - blood pressure

Time frame:6 months after enrollment

descriptive

Other/protocol endpoint

Vital signs - heart rate

Time frame:6 months after enrollment

Heart rate, change

change from baseline, improvement

Other/protocol endpoint

Metabolic, inflammatory and appetite hormones in pg/mL

Time frame:6 months after enrollment

concentration, descriptive

Patient-reported / QoL

1 endpoint
Other/protocol endpoint

Quality of Life Measurement as assessed by the SF-36 questionnaire

Time frame:6 months after enrollment

SF-36 total

descriptive, improvement

Other (unclassified)

6 endpoints
Primary/protocol endpoint/low confidence

cfPWV measurement and pulse wave analysis (PWA) using SphygmoCorCvMS V9 (AtCor Medical)

Time frame:6 months after enrollment

descriptive

Other/protocol endpoint/low confidence

Dietary Assessment using 24-hour recalls

Time frame:6 months after enrollment

descriptive

Other/protocol endpoint/low confidence

Dietary Assessment using adherence questionnaires

Time frame:6 months after enrollment

descriptive

Other/protocol endpoint/low confidence

Genetic studies

Time frame:6 months after enrollment

descriptive

Other/protocol endpoint/low confidence

Metabolic, inflammatory and appetite hormones in pmol/L

Time frame:6 months after enrollment

concentration, descriptive

Other/protocol endpoint/low confidence

Metabolic, inflammatory and appetite hormones in ng/mL

Time frame:6 months after enrollment

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.